# K131398: Novoknee Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Novosource, Inc.
- Decided: Sep 16, 2013 after 124 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021657 (2002). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123339: TK1 Total Knee System, Novosource, Inc. (2013) Summary page 1.
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006) Summary page 1.

## Most influential descendants
- K150783: Progressive Orthopaedic Total Knee System (2015), 8 descendants of its own
- K170753: Acculoc Total Knee System (2018), 3 descendants of its own
- K261032: NovoKnee (SteriKnee) (2026), 0 descendants of its own
- K231975: PNK Total Knee System (2023), 0 descendants of its own
- K210695: CPM Medical Consultants Tibial Revision Knee System (2021), 0 descendants of its own

## Indications for use
The NovoKnee Total Knee System IsIndicated In knee arthroplasty for reduction or relief of pain and/or improved knee function Inskeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss-of joint configuration, particularly when there is pateilofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System isdesigned for cemented use only.

Source page: https://510kreport.com/device/K131398
Methodology: https://510kreport.com/methodology